Reporting a falsified product to EMA
Marketing and manufacturing authorisation holders should report any falsified centrally authorised medicine to the European Medicines Agency (EMA), including a suspected falsified medicine, following the instructions provided.
Step 1. Notify EMA
For guidance on using the template, see:
You should receive an acknowledgement in four hours during EMA business hours. If you do not, you can phone EMA on:
Outside of EMA business hours, use the following urgent contact number:
Step 2. Provide authenticity testing report
Provide the authenticity testing report, describing whether the falsification is confirmed or not.
For a confirmed falsification, provide details of the discrepancies in relation to the authentic product (for example, the outer labelling or content).
If these final reports are not available when notifying EMA, provide interim reports, as requested by EMA.
Parallel distributors notifying EMA of a suspected falsified medicine before informing the marketing authorisation holder should also liaise directly with the marketing authorisation holder and provide a sample of the suspicious unit for authenticity testing.
Step 3. Keep EMA informed
|Keep EMA immediately informed of any changes or additional information.|